Recruiting

Phase 3

GSK5784283A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-2)

Sponsor:

GlaxoSmithKline

Code:

NCT07782996

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

GSK5784283

Placebo

Standard of care

Study Details

Brief summary:

The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.

Conditions

Asthma

Study ID

NCT07782996

Start date

Aug 27, 2026

Status verified date

Nov, 2026

Completion date

Dec 28, 2029

Anticipated

Primary completion date

May 4, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF), For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed consent from their Legally acceptable representative (LAR).
Participants aged 12 to 80 years at the time of signing the informed consent.
Male or eligible female participants:

Female participants:

A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

i. Is a Participant of non-childbearing potential (PONCBP) or ii. Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<) 1 percent (%), 28 days prior to the first dose of the study drug, and during the study intervention period and follow-up period for at least 60 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.

A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention.
If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Contraceptive use by women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical trials.
A documented physician diagnosis of asthma for at least 12 months prior to Visit 1, according to the Global Initiative for Asthma (GINA) 2026 guidelines.
Evidence of variable airflow obstruction consistent with asthma.
Documented history of asthma exacerbation within 12 months prior to Visit 1.
A well-documented requirement for regular treatment with medium or high dose Inhaled corticosteroid (ICS) for at least 3 months prior to screening with or without maintenance oral corticosteroids (OCS).
At least 1 additional maintenance asthma controller medication is required according to standard practice of care (e.g., Long-acting beta-2 agonist \[LABA\], Leukotriene receptor antagonists \[LTRA\], theophylline, Long-acting muscarinic agonists \[LAMA\], chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to screening.
Uncontrolled asthma based on ACQ-5 score.

Exclusion Criteria:

Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results.
History of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).
Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.
New York Heart Association (NYHA) class III or IV heart failure.
Other significant medical conditions that could impact participants' safety or study outcomes.
History of an unresolved clinically significant infection within 30 days prior to Visit 1.
A known immunodeficiency other than that explained by the use of corticosteroids taken as therapy for asthma.
Receipt of any marketed or investigational biologic agent or investigational non-biologic agent, prior to Visit 1.
Use of systemic immunosuppressive medication within 3 months prior to Visit 1 (other than systemic corticosteroid burst or stable maintenance OCS for treatment of asthma).
Current smokers (tobacco and/or marijuana), current users of vaping products/electronic-cigarettes or participants with a smoking history >=10 pack-years.

Study Design

Enrollment

370 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants receiving GSK5784283 plus standard of care

placebo comparator: Participants receiving matching placebo plus standard of care

Interventions

GSK5784283

GSK5784283 will be administered.

Placebo

Placebo will be administered.

Standard of care

Standard of care will be administered.

Primary outcome measure

Annualized rate of clinically significant asthma exacerbations [ Time Frame: Up to Week 52 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

San Diego, California, United States, 92120

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Scott Evans

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33135

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Omar Benitez

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33135

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Idania Fernandez

GSK Investigational Site

Recruiting

Miami Lakes, Florida, United States, 33014-2479

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Raiko Diaz

GSK Investigational Site

Recruiting

Tampa, Florida, United States, 33607-6616

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Manuel Gomez

GSK Investigational Site

Recruiting

Southfield, Michigan, United States, 48075

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Syed Talib Raza

GSK Investigational Site

Recruiting

Albuquerque, New Mexico, United States, 87106-5214

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sally Fisher

GSK Investigational Site

Recruiting

DuBois, Pennsylvania, United States, 15801-2277

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sandeep Bansal

GSK Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

David Wheeler

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77074

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Zeeshan Shaikh

GSK Investigational Site

Recruiting

Humble, Texas, United States, 77338-3916

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Atul Matta

GSK Investigational Site

Recruiting

Tomball, Texas, United States, 77375-3332

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mustafa Naeem

More Information

Sponsor

GlaxoSmithKline

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

Asthma
Felcorekibart
GSK5784283
Placebo
Standard of care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.